Super High Hat Safety Pin
Catalogue number 202-412, listed by TP Orthodontics, Inc., United States, under Spring, Orthodontic. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
1catalogue number
13recalls on this code
Who Else Makes It
Concentrated in Zhejiang (8), Guangdong (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Guangzhou Cheer-U Material Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
Showing 12 of 22. All 22 manufacturers in China registered for Spring, Orthodontic
Record
| Listed by | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | ECO |
| Device type | Spring, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202-412 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RMO | RMO | 57 |
| 3M™ Unitek™ | 3M Unitek | 51 |
| Aditek | Aditek DO Brasil S/A | 47 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 40 |
| 3M™ Forsus™ | 3M Unitek | 35 |
| Masel | Ortho Organizers, Inc. | 33 |
| The Orthodontic Store | Young Innovations Inc. | 31 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 30 |
| Mico One Orthodontic Spring | ZE Fang Technology Co., Ltd. | 29 |
| NiTi Spring | American Orthodontics | 26 |
| Orthodontic Spring | Dentos, Incorporated | 25 |
| Phoenix Nickel Titanium | Phoenix Orthodontics Inc | 21 |
Showing 12 of 168. All products under Spring, Orthodontic
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 10 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 0 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 108 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 7 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 7 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 1 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 1 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 5 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 126 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 5 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 119 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 1 | 2020-04-15 |
| 2018-05-01 | Class II | Device Design | The firm has received 106 complaints of the device breaking in the patient’s mouth. Device breakage may cause injury to the patient. | 5 | 2020-04-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.